COMMISSION IMPLEMENTING REGULATION (EU) 2023/113
of 16 January 2023
authorising the placing on the market of 3′-Sialyllactose sodium salt produced by derivative strains of
Escherichia coli
BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
Article 1
Article 2
Article 3
Article 4
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
Data Protection |
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‘3′-Sialyllactose (‘3′-SL’) sodium salt (produced by derivative strains of E. coli BL21(DE3)) |
Specified food category |
Maximum levels |
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3′-Sialyllactose sodium salt’. The labelling of food supplements containing 3′-Sialyllactose (3′-SL) sodium salt shall bear a statement that
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Authorised on 6 February 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: “Chr. Hansen A/S”, Boege Allé 10-12, 2970 Hoersholm, Denmark. During the period of data protection, the novel food 3′-Sialyllactose sodium salt is authorised for placing on the market within the Union only by Chr. Hansen A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of “Chr. Hansen A/S”. End date of the data protection: 6 February 2028.’ |
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Infant formula as defined under Regulation (EU) No 609/2013 |
0,23 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
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Follow-on formula as defined under Regulation (EU) No 609/2013 |
0,28 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
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Processed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/2013 |
0,28 g/L or 0,28 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
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Milk based drinks and similar products intended for young children |
0,28 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
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Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013 |
In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher 0,23 g/L or 0,28 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. |
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Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children |
In accordance with the particular nutritional requirements of the persons for whom the products are intended |
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Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children |
0,7 g/day |
Authorised novel food |
Specification |
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‘3′-Sialyllactose (‘3′-SL’) sodium salt (produced by derivative strains of E. coli BL21(DE3)) |
Description: 3'-Sialyllactose (3′-SL) sodium salt is a purified, white to off-white powder or agglomerate produced by a microbial process and contains limited levels of lactose, 3'-sialyl-lactulose, and sialic acid. Definition: Chemical name: N-Acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt Chemical formula: C23H38NO19Na Molecular mass: 655,53 Da CAS No: 128596-80-5 Source: Two genetically modified strains (a production strain and an optional degradation strain) of Escherichia coli BL21(DE3) Characteristics/Composition:
Microbiological criteria: Standard plate count: ≤ 1 000 *CFU/g Enterobacteriaceae: ≤ 10 CFU/g Salmonella spp.: Absence in 25 g Yeast and mould: ≤ 100 CFU/g Cronobacter (Enterobacter) sakazakii: Absence in 10 g Residual endotoxins: ≤ 10 **EU/mg
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